[Federal Register: October 29, 2003 (Volume 68, Number 209)]
[Notices]               
[Page 61670-61671]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29oc03-39]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0486]

 
Determination That PIPRACIL (Piperacillin Sodium) 2-Gram, 3-Gram, 
and 4-Gram Vials Were Not Withdrawn From Sale for Reasons of Safety or 
Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined that 
PIPRACIL (piperacillin sodium) 2-gram, 3-gram, and 4-gram vials were 
not withdrawn from sale for reasons of safety or effectiveness. This 
determination will allow FDA to approve abbreviated new drug 
applications (ANDAs) for piperacillin sodium 2-gram, 3-gram, and 4-gram 
vials.

FOR FURTHER INFORMATION CONTACT: Nicole Mueller, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price 
Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) 
(the 1984 amendments), which authorized the approval of duplicate 
versions of drug products approved under an ANDA procedure. ANDA 
sponsors must, with certain exceptions, show that the drug for which 
they are seeking approval contains the same active ingredient in the 
same strength and dosage form as the ``listed drug,'' which is a 
version of the drug that was previously approved. Sponsors of ANDAs do 
not have to repeat the extensive clinical testing otherwise necessary 
to gain approval of a new drug application (NDA). The only clinical 
data required in an ANDA are data to show that the drug that is the 
subject of the ANDA is bioequivalent to the listed drug.
    The 1984 amendments include what is now section 505(j)(7) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which 
requires FDA to publish a list of all approved drugs. FDA publishes 
this list as part of the ``Approved Drug Products with Therapeutic 
Equivalence Evaluations,'' which is generally known as the ``Orange 
Book.'' Under FDA regulations, drugs are withdrawn from the list if the 
agency withdraws or suspends approval of the drug's NDA or ANDA for 
reasons of safety or effectiveness or if FDA determines that the listed 
drug was withdrawn from sale for reasons of safety or effectiveness 
(Sec.  314.162) (21 CFR 314.162)).
    Under Sec.  314.161(a)(1) (21 CFR 314.161(a)(1)), the agency must 
determine whether a listed drug was withdrawn from sale for reasons of

[[Page 61671]]

safety or effectiveness before an ANDA that refers to that listed drug 
may be approved. FDA may not approve an ANDA that does not refer to a 
listed drug.
    PIPRACIL (piperacillin sodium) 2-gram, 3-gram, and 4-gram vials are 
the subject of approved NDA 50-545 held by Lederle (part of Wyeth-
Ayerst Pharmaceuticals). PIPRACIL is a broad-spectrum penicillin 
indicated for the treatment of serious infections and for prophylactic 
use in surgery. The holder of the application for PIPRACIL 
(piperacillin sodium) 2-gram, 3-gram, and 4-gram vials has informed FDA 
that the drug products have been withdrawn from sale.
    The agency has determined that Wyeth-Ayerst's PIPRACIL 2-gram, 3-
gram, and 4-gram vials were not withdrawn from sale for reasons of 
safety or effectiveness. FDA has independently evaluated relevant 
literature and data for possible postmarketing adverse event reports 
and has found no information that would indicate these products were 
withdrawn for reasons of safety or effectiveness.
    For the reasons outlined, FDA determines that Wyeth-Ayerst's 
PIPRACIL 2-gram, 3-gram, and 4-gram vials were not withdrawn from sale 
for reasons of safety or effectiveness. Accordingly, the agency will 
continue to list PIPRACIL (piperacillin sodium) 2-gram, 3-gram, and 4-
gram vials in the ``Discontinued Drug Product List'' section of the 
Orange Book. The ``Discontinued Drug Product List'' delineates, among 
other items, drug products that have been discontinued from marketing 
for reasons other than safety or effectiveness. ANDAs that refer to 
PIPRACIL (piperacillin sodium) 2-gram, 3-gram, and 4-gram vials may be 
approved by the agency.

    Dated: October 21, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-27190 Filed 10-28-03; 8:45 am]

BILLING CODE 4160-01-S